The
Icelandic Medicines Agency (IMA) has decided to revoke the S-classified status
of medicinal products that have also been used outside the hospital environment
as well as for products which are now not considered to be limited to hospital
use. With this change the S-classification will only apply to medicinal
products that are exclusively used in the hospital environment, where the right
facilities, expertise and equipment is in place which is essential for correct
use. This change will take effect on January 1st 2019.

According
to Article 8(1) of the Medicinal Products Act No 93/1994 The IMA can limit a
marketing authorisation (MA) for a medicinal product to hospital use
(S‑classification). This is further specified in newly enacted regulation that
took effect in May 2018.

Review of
S-classified medicinal products has been on the IMA‘s agenda for a long time as
seen in earlier news reported on this site in December 2012 and May 2013. In 2012 the IMA evaluated all the
S-classified medicinal products that had MA in Iceland at that time. MA holders
were notified of the review and given time to comment. MA holders were also
notified that the cancellation of the S-classification can potentially result
in the need for reimbursement application to be submitted to the Icelandic
Medicine Pricing and Reimbursement Committee. Since the 2012 review MA holders
have been made aware of the upcoming review of S-classified medicinal products
when a marketing authorisation is issued.

As
mentioned above the aforementioned changes will take effect on January 1st 2019. Until that
date all parties involved can prepare for the changes. Possible counter
measures include changes in regulations, new reimbursement applications to be submitted,
new budget items to account for in the state budget and possibly new
reimbursement decisions to be implemented for products which have had S-classification.
These changes will also affect medicinal products without MA in Iceland, that
are listed by the Icelandic Medicine Pricing and Reimbursement Committee and
used on a named-patient basis.

The lists are as follows:

List
of authorised medicinal products for which the S-classification will be revoked
on January 1st 2019.

List
of authorised and marketed medicinal products for which the S-classification
will be revoked on January 1st 2019.

List
of named-patient basis use medicinal products for which the
S-classification will be revoked on January 1st 2019.

Please note that the lists are still under review.

The lists
will be updated at the beginning of each month because temporary
S-classification will continue until these changes take effect on January 1st
2019. The lists can be found under Publications -> Lists on our website.

If you have
any questions or comments please contact us by email: ima@ima.is. Subject: S-classification – comments.